Job Description – Associate Specialist (Cell Therapy Manufacturing)

Job Title: Associate Specialist – Cell Therapy Manufacturing
Location: Rockville, MD 20850 (Onsite)
Duration: 12 Months (Possibility of Extension)
Work Schedule: Wednesday – Saturday | 7:00 AM – 5:30 PM

Job Summary

We are seeking an Associate Specialist – Cell Therapy Manufacturing to support clinical manufacturing operations within a cGMP-regulated cell therapy environment. This role involves manufacturing next-generation cell therapy products, maintaining GMP documentation, operating automated manufacturing equipment, and collaborating with cross-functional teams to ensure the successful production of clinical materials. The ideal candidate will have a strong scientific background, excellent communication skills, adaptability, and experience with aseptic manufacturing techniques.

Key Responsibilities

• Author, execute, and maintain manufacturing batch records, SOPs, work instructions, and bill of materials.

• Complete batch record reconciliation and ensure timely, accurate GMP documentation.

• Assist with deviations, non-conformance investigations, and out-of-specification (OOS) investigations.

• Operate, monitor, clean, and prepare automated cell processing, cell expansion, and filling equipment.

• Perform manufacturing activities within Grade A and Grade B cleanroom environments following aseptic techniques.

• Train manufacturing personnel on cGMP practices, aseptic processing, equipment operation, and documentation requirements.

• Review manufacturing documentation, logbooks, and SOPs for accuracy and completeness.

• Participate in technology transfer activities and process development initiatives.

• Support process improvements and optimization within the clinical manufacturing environment.

• Lead manufacturing floor activities, assign tasks, communicate product status during shift changes, and troubleshoot equipment or process issues.

• Maintain compliance with cGMP regulations and workplace safety standards.

• Collaborate with Process Development, Clinical Operations, Materials Management, and Quality teams.

• Support weekend operations as required.

Required Qualifications

• Bachelor's or Master's degree in Life Sciences, Biotechnology, Engineering, or a related scientific field.

• Bachelor's degree with 0–3 years of cGMP manufacturing experience, or

• Master's degree with 0–2 years of cGMP manufacturing experience.

• Basic knowledge of biologics manufacturing processes, cell culture, or viral vector products.

• Experience with aseptic techniques and manufacturing in cleanroom environments.

• Familiarity with automated manufacturing equipment and/or process analytical technologies.

• Proficiency in Microsoft Word, Excel, and basic data analysis.

Preferred Qualifications

• Experience in cell therapy or viral vector manufacturing.

• Exposure to process development or technology transfer activities.

• Strong troubleshooting and problem-solving skills.

• Ability to work independently with minimal supervision.

• Adaptability in a fast-paced cGMP manufacturing environment.

• Excellent interpersonal and cross-functional communication skills.

Required Skills

• cGMP Manufacturing

• Aseptic Processing

• Cell Culture

• Biologics Manufacturing

• Cleanroom Operations

• Batch Record Documentation

• SOP Authoring

• Manufacturing Equipment Operation

• Microsoft Word & Excel

• Process Improvement

• Technical Documentation

• Cross-Functional Collaboration

• Problem Solving

• Communication Skills

Manager's Top Requirements

• Strong communication skills

• Adaptability and flexibility

• Hands-on aseptic technique and manufacturing floor experience

Work Environment

• Fully onsite position.

• Work in Grade A and Grade B cleanroom environments.

• Weekend work may be required.

Cleanroom & PPE Requirements

Candidates must comply with strict cleanroom and PPE guidelines, including:

• No jewelry (including smartwatches or fitness bands).

• No cosmetics except non-pigmented, non-scented moisturizer and lip balm.

• No nail polish, artificial nails, or eyelash extensions.

• No recent tattoos, piercings, or open wounds while working in the manufacturing environment.

Interview Process

• One panel interview with the Hiring Manager (virtual or onsite based on scheduling).

#IND2 JC - R6

Pay: $25.00 - $27.00 per hour

Benefits:

• 401(k)

• Dental insurance

• Health insurance

Application Question(s):

• Are you a US Citizen or GCH? If on Visa please mention the Visa Status

• Are you ready for background check and drug screen in accordance with the local law and regulations?

• Cube Hub payroll is Bi-Weekly, we pay every-other-Friday. Are you Comfortable with Bi-Weekly payroll policy?

• What is your Expected Pay Range?

• Could you please confirm your email and contact Number?

• Do you have experience working in a cGMP manufacturing or cleanroom environment using aseptic techniques?

• Are you comfortable working onsite in Rockville, MD, Wednesday through Saturday from 7:00 AM to 5:30 PM?

• Are you able to comply with cleanroom PPE requirements, including restrictions on jewelry, cosmetics, artificial nails, and recent tattoos or piercings?

Education:

• Bachelor's (Required)

Work Location: In person